What is NDC 47781-398?

47781-398 is the product NDC for Hydrocodone Bitartrate, Hydrocodone bitartrate 120 mg/1 tablet, extended release, listed with the FDA by Alvogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Alvogen Inc., NDC labeler code 47781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydrocodone Bitartrate?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydrocodone Bitartrate NDC 47781-398

NDC codes

FDA NDC Directory

Product NDC (as listed)47781-398Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47781-0398Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
47781-398-60	4778103986047781039860	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-398-60)Marketed from Mar 3, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Hydrocodone Bitartrate
Generic name (nonproprietary): hydrocodone bitartrate
Active ingredients: Hydrocodone bitartrate — 120 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Alvogen Inc.NDC labeler code 47781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208269
Marketing start: Mar 3, 2021
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 47781-398_c0f6333c-1d3f-3519-b157-cf817bd5c81dSPL ID c0f6333c-1d3f-3519-b157-cf817bd5c81dSPL set ID f7b55d14-0980-b680-8ceb-7489ff65455eRxCUI 1595730, 1595740, 1595746, 1595752, 1595758, 1595764, 1595770UNII NO70W886KKUPC 0347781394608, 0347781397609, 0347781395605, 0347781398606, 0347781392604, 0347781396602, 0347781393601
Pharmacologic class: Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N447781039860 followed by a unit qualifier and the quantity

Package 47781-0398-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 7, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47781-398

What is NDC 47781-398?: 47781-398 is the product NDC for Hydrocodone Bitartrate, Hydrocodone bitartrate 120 mg/1 tablet, extended release, listed with the FDA by Alvogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydrocodone Bitartrate.
What is the active ingredient?: Hydrocodone bitartrate.
Who is the labeler?: Alvogen Inc., NDC labeler code 47781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydrocodone Bitartrate?: 12 other product NDCs are listed under this name. See all Hydrocodone Bitartrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hydrocodone Bitartrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydrocodone Bitartrate	Hydrocodone bitartrate 20 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-392	47781-0392-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 30 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-393	47781-0393-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 40 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-394	47781-0394-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 60 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-395	47781-0395-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 80 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-396	47781-0396-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 100 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-397	47781-0397-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 10 mg/1	Capsule, Extended releaseOral	Alvogen Inc.	47781-409	47781-0409-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 15 mg/1	Capsule, Extended releaseOral	Alvogen Inc.	47781-410	47781-0410-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 20 mg/1	Capsule, Extended releaseOral	Alvogen Inc.	47781-411	47781-0411-60
Hydrocodone Bitartrate	Hydrocodone bitartrate 30 mg/1	Capsule, Extended releaseOral	Alvogen Inc.	47781-412	47781-0412-60

All 13 Hydrocodone Bitartrate NDCs

Other NDCs under ANDA 208269

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208269
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate	Hydrocodone bitartrate 20 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-392
Hydrocodone Bitartrate	Hydrocodone bitartrate 30 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-393
Hydrocodone Bitartrate	Hydrocodone bitartrate 40 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-394
Hydrocodone Bitartrate	Hydrocodone bitartrate 60 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-395
Hydrocodone Bitartrate	Hydrocodone bitartrate 80 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-396
Hydrocodone Bitartrate	Hydrocodone bitartrate 100 mg/1	Tablet, Extended releaseOral	Alvogen Inc.	47781-397